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Safety and Immunogenicity of Sequential Pneumococcal Immunization in Preschool Asthmatics (PAPSI)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Markus Rose, Johann Wolfgang Goethe University Hospitals
ClinicalTrials.gov Identifier:
NCT00836641
First received: February 3, 2009
Last updated: April 16, 2012
Last verified: April 2012
History of Changes
  Purpose

Asthma is a major health problem in preschool children. Infections by pneumococci a the most frequent cause of airway infections, which tend to cause worsening of asthma. Vaccination against pneumococci is recommended by scientific boards and the medical community, in order to reduce the burden of disease. Data on the immunogenicity and safety of pneumococcal immunization in preschool asthmatics are scarce.


Condition Intervention Phase
Asthma
 Biological: prevenar
Biological: pneumovax
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Prospective Randomized Controlled Phase 4 Study on the Safety and Immunogenicity of Sequential Pneumococcal Immunization in Preschool Asthmatics

Resource links provided by NLM:

MedlinePlus related topics: Asthma
U.S. FDA Resources

Further study details as provided by Johann Wolfgang Goethe University Hospitals:

Primary Outcome Measures:
  • immunogenicity of pneumococcal vaccination [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • safety and tolerability of pneumococcal immunization [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

Enrollment: 70
Study Start Date: October 2006
Study Completion Date: December 2008
Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: pneumococcal immunzation
one dose of pneumococcal conjugate vaccine followed after 2 months by one dose of pneumococcal polysaccharide vaccine
 Biological: prevenar
7-valent pneumococcal conjugate vaccine
Other Name: Prevnar, PCV-7
Biological: pneumovax
23 valent pneumococcal polysaccharid vaccine
Other Name: pneumopur, PPV-23
Active Comparator: 2
one dose of pneumococcal conjugate vaccine followed after 10 months by one dose of pneumococcal polysaccharide vaccine
 Biological: prevenar
7-valent pneumococcal conjugate vaccine
Other Name: Prevnar, PCV-7
Biological: pneumovax
23 valent pneumococcal polysaccharid vaccine
Other Name: pneumopur, PPV-23

Detailed Description:

Respiratory infections are major triggers of exacerbations in preschool asthma. Many countries' guidelines recommend immunization against pneumococci for patients suffering from chronic airway disease. Also the interval between priming and booster is a matter of debate.

We immunize a large group of preschool asthmatics (2-5 years old) sequentially: one dose of seven-valent pneumococcal conjugate vaccine (PCV-7) followed by a single dose of 23-valent pneumococcal polysaccharide vaccine (PPV-23). We randomly assign half of the vaccinees to receive PPV-23 eight weeks after PCV-7 (group A), and the rest to a 10-month interval (group B). Pneumococcal antibody concentrations to serotype 4, 5, 6B, 7, 9V, 14, 18c, 19F, and 23F are determined initially, after two, and 12 months after PCV-7. Local and systemic reactions to each vaccine are recorded.

  Eligibility

Ages Eligible for Study:   2 Years to 5 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • asthma GINA °1-2

Exclusion Criteria:

  • antecedent pneumococcal immunization
  Contacts and Locations
No Contacts or Locations Provided
  More Information

Publications:

Responsible Party: Markus Rose, Professor of Paediatrics, Johann Wolfgang Goethe University Hospitals
ClinicalTrials.gov Identifier: NCT00836641     History of Changes
Other Study ID Numbers: PAPSI.FFM.3217
Study First Received: February 3, 2009
Last Updated: April 16, 2012
Health Authority: Germany: Paul-Ehrlich-Institut

Keywords provided by Johann Wolfgang Goethe University Hospitals:
preschool asthma
sequential pneumococcal immunization
immunogenicity
safety

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
 Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases

ClinicalTrials.gov processed this record on May 23, 2013